Electronic Product Information (ePI) offers a different approach. Instead of relying on print cycles, approved product information is published digitally and updated centrally. The first rollout phase begins in 2026.
What is ePI?
ePI stands for Electronic Product Information. It is product information in a structured electronic format, covering the same three regulated documents companies already manage: the Summary of Product Characteristics (SmPC), the Package Leaflet (PIL), and the product labeling.
The information stays the same. The delivery model changes.
Instead of relying only on printed leaflets and packaging updates, companies publish approved product information digitally through EMA’s Product Lifecycle Management (PLM) Portal.
Patients and healthcare professionals access the latest approved information through digital channels, including QR codes on product packaging.
Where ePI Stands Right Now
ePI has moved beyond discussion and early planning.
The pilot ran from July 2023 to August 2024. It involved the EMA and four national competent authorities. The pilot tested how ePI would work across regulatory processes, systems, and real product information.
In December 2024, the EMA confirmed that the system was ready for phased implementation.
The voluntary rollout timeline by therapeutic area is:
- Vaccines (ATC code J07): Q3 2026
- Oncology products (ATC codes L01 and L04): Q4 2026
- All other Centrally Authorized Products: progressive expansion after Q4 2026
Participation remains voluntary for now. ePI will become mandatory after the revised EU pharmaceutical legislation takes effect.
Prepare Your Translation Workflows for the ePI
How the Current Paper System Works and Where It Fails
EU pharmaceutical regulations require that the SmPC, PIL, and labeling be presented in the official language of every member state where the medicine is placed on the market.
For a product sold across the EU, that means up to 24 language versions of each document, all physically printed and distributed. This system works well for stable products. It breaks down at the update stage.
When a variation is approved, whether a safety update, dosage change, or new indication, the labeling team must:
- Update the master document
- Commission retranslation across affected language versions
- Run review cycles, and
- Coordinate reprints with packaging suppliers and distributors
By the time updated packaging reaches patients, the approval may be weeks old.
Also Read: EU CTR 536/2014: Translation Requirement
What Changes When ePI Is Adopted
Under ePI, the approved product information lives in a central digital repository. When a variation is approved and the document is updated, the change becomes immediately accessible to anyone who scans the QR code on the packaging.
There is no reprint cycle for the content.For labeling teams, this removes the bottleneck between regulatory approval and patient access. It also reduces long-term packaging costs and supply chain complexity tied to language version management.
What ePI Means for Translation Teams
ePI does not reduce translation obligations.
Product information must still be available in the required official languages for every market where the medicine is sold. During the early rollout for centrally authorized products, English will come first. Other languages may remain optional during the initial technical phase. This supports implementation. It does not remove the long-term requirement for multilingual product information.
The main change lies in timing. Translation will move closer to the point of regulatory approval. Updates that once waited for packaging schedules will need faster linguistic review, quality checks, and publication readiness.
Translation becomes a continuous part of the labeling workflow.
Also Read: EU Biotech Act 2026: A Translation and Localization Checklist
What Labeling Teams Should Do Now
ePI is voluntary today. But the direction is set, and companies that start adapting early will be in a much stronger position than those who wait for the mandate.
- Identify your go-live window. Vaccines and oncology products face the earliest voluntary timelines. Know where your portfolio sits on the roadmap.
- Audit your translation workflow for batch dependencies. If your process is built around print cycles, it will need to be restructured. Identify the bottlenecks before they become compliance risks.
- Review your vendor arrangements. Contracts built around project-based delivery may not support the turnaround speeds that continuous, approval-driven translation requires. Discuss this with your language service provider now.
- Treat digital ePI content as regulated from day one. Quality, accuracy, and traceability requirements are identical to paper. The format is different. The compliance standard is not.
ePI Does Not Mean Less Translation. It Means Faster Translation.
The ePI pilot is complete. The rollout roadmap is published. The first voluntary implementations begin in 2026. Translation obligations are not going away. What changes is the pace at which they must be met. Teams with flexible translation processes and faster turnaround capabilities will be better positioned for this shift.
The best time to prepare is now, before ePI becomes a routine part of EU pharmaceutical labeling.
Make Your Translation Process Ready for ePI
FAQs
What is Electronic Product Information (ePI)?
Why is the EU introducing ePI?
The EU is introducing ePI to improve access to current product information and support more efficient regulatory updates. Under the traditional model, approved changes often require packaging updates and reprints before reaching patients. ePI enables approved information to be updated centrally and made available digitally much faster.
When will ePI be implemented in the European Union?
Does ePI remove the need for pharmaceutical translation?
How will ePI affect pharmaceutical translation workflows?
ePI will make translation workflows more continuous and approval-driven. Instead of waiting for packaging reprints or scheduled updates, translation teams may need to prepare multilingual content more quickly following regulatory approvals, ensuring information can be published digitally without delay.
What are the benefits of ePI for labeling teams?
ePI can simplify version control, reduce dependence on packaging reprints, improve access to current information, and shorten the time between regulatory approval and patient access. It also supports a centralized approach to managing product information across multiple markets.
How will patients and healthcare professionals access ePI?
Patients and healthcare professionals will be able to access approved product information through digital channels, including QR codes on medicine packaging. This allows users to view the latest approved version of product information without waiting for new printed materials to be distributed.
What should pharmaceutical companies do to prepare for ePI?
Companies should review their labeling, regulatory, and translation processes to identify dependencies on print-based workflows. They should also evaluate whether their translation providers can support faster turnaround times and ensure that digital product information meets the same quality and compliance standards as printed content.
